Rabbitt Antiserum to Human C3C
FDA 510(k) K831905 · Dako Corp.
510(k) numberK831905
Submission
- Device name
- Rabbitt Antiserum to Human C3C
- Applicant
- Dako Corp.
Mchenry, IL, US - Received
- June 14, 1983
- Decision date
- July 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZW – Complement C3, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code CZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100179 | SpaplusCZW · Traditional | The Binding Site Group , Ltd. | 08/13/2010SE |
| K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High ControlCZW · Traditional | Thermo Electron OY | 03/19/2007SE |
| K061852 | Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…CZW · Traditional | Dade Behring, Inc. | 09/22/2006SE |
| K050665 | N Antisera to Human Complement Factors (C3C, C4)CZW · Traditional | Dade Behring, Inc. | 05/02/2005SE |
| K042494 | Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…CZW · Traditional | Ortho-Clinical Diagnostics | 10/19/2004SE |
| K032796 | Ibl C3D-CIC Eia TestCZW · Traditional | Ibl GmbH | 01/13/2004SE |
| K032035 | Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…CZW · Traditional | Beckman Coulter, Inc. | 08/07/2003SE |
| K012361 | Tina-Quant Complement C3C Test SystemCZW · Traditional | Roche Diagnostics Corp. | 11/29/2001SE |
| K010326 | Wako Autokit C3CZW · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K000469 | Randox Complement C3CZW · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for…MXZ · Traditional | 02/28/2002SE |
| K993957 | Dako Monoclonal Mouse Anti-Human Estrogen ReceptorMYA · Traditional | 03/03/2000SE |
| K991454 | Mouse IGG1 Negative ControlsGKZ · Traditional | 06/21/1999SE |
| K991402 | Dako Mouse Anti-Human T-Cell, CD3/RPE-CY5, Clone UCHT1 & Dako Mouse Anti-Human T-Cell…GKZ · Traditional | 06/21/1999SE |
| K980635 | Dako Mouse Anti-Human B-Cell, CD19/RPE-CY5, Clone HD37GKZ · Traditional | 07/22/1998SE |
| K971905 | Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal…DEH · Traditional | 12/12/1997SE |
| K965022 | Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, BER-H2 Antibody for Immunoenzymatic…DEH · Traditional | 11/06/1997SE |
| K964974 | Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/RpeGKZ · Traditional | 06/24/1997SE |
| K961701 | Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) RpeGKZ · Traditional | 07/16/1996SE |
| K951965 | Dako Labeled Streptavidin-Biotin 2 Kit, and EnvisionDEH · Traditional | 07/05/1996SE |
Questions and answers
When was Rabbitt Antiserum to Human C3C cleared by the FDA?
Rabbitt Antiserum to Human C3C (K831905) received a 510(k) decision of Substantially Equivalent on July 18, 1983, 34 days after the submission was received.
What is the product code of K831905?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.